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NCT Number: NCT04229056

COMPuter-assisted Self-training to Improve EXecutive Function

This project explores the effects of specialized computer-based cognitive rehabilitation (CBCR) targeting executive functions in three groups of patients: Stroke, Cardiac Arrest and Parkinson's Disease. The effect of specialized CBCR is compared to generally cognitively stimulating activities on a computer

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Cardiac Arrest Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Dysfunction Executive Dysfunction Heart Arrest Heart Diseases Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinsonian Disorders Stroke Synucleinopathies Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital, Copenhagen, Denmark

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About this study

This project explores the effects of specialized computer-based cognitive rehabilitation (CBCR) targeting executive functions in three groups of patients: Stroke, Cardiac Arrest and Parkinson's Disease. The effect of specialized CBCR is compared to completing generally cognitively stimulating activities on a computer. A total of 307 patients is expected to be enrolled. All patients will complete a neuropsychological test battery assessing executive functions at inclusion, directly after the eight-week training period and at follow-up three months after the end of the intervention period. Furthermore, all patients will answer questionnaires concerning quality of life and ADL-measures at baseline, after the intervention and at follow-up. All patients will train for a period of 8 weeks, 5 times a week for 60 minutes regardless of their group allocation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A diagnose of stroke, cardiac arrest or Parkinson's disease.
  • Aged 18 years or older.
  • Impaired working memory measured with CABPad working memory test, cut off for inclusion: 5 symbols or less backwards
  • Computer and internet access at home.
  • Providing informed consent.

Inclusion criteria

specific for stroke

  • Inclusion within 6 months post-stroke
  • Stroke confirmed by clinical findings and imaging, both AIS and ICH is allowed.
  • Initial stroke severity >/= NIHSS 3.

Inclusion criteria

specific for cardiac arrest

  • Inclusion within 6 months post ictus.

Inclusion criteria

specific for Parkinson's disease

  • Clinical diagnosis of PD.
  • Anti-parkinsonian medical treatment (dopaminergic or other).

Exclusion criteria

  • Informed consent not provided
  • Other neurological or psychiatric disease which is expected to influence the patient's ability to participate in the trial according to the investigator
  • Not able to participate according to investigator

Exclusion criteria

specific for stroke

  • Patients with massive anosognosia for executive dysfunction or patients with no subjective feeling of executive dysfunction (Patient sustains total denial of executive symptoms over time)
  • Patients with severe aphasia, in which it is unclear whether the patient's performance on a neuropsychological test-battery is due to aphasia and not executive dysfunction.

Exclusion criteria

specific for cardiac arrest • None

Exclusion criteria

specific for PD

  • Diagnosis of PD Dementia according to the MDS PD Dementia criteria

Treatment and study plan

Computer-based cognitive rehabilitation (CBCR)

Behavioral

CBCR are software-programmes for computers which are clinically developed for rehabilitation of various cognitive functions.

General computer-based cognitive stimulation

Behavioral

For this trial we have developed a webpage for general cognitive stimulation, which is designed to provide general computer-based cognitive stimulation.

Primary outcomes

  1. CABPad Working Memory Test

    Time frame: After the end of the intervention (8 weeks after baseline)

    Test of working memory. The higher score the better (theoretically infinite score)

Secondary outcomes

  1. CABPad Working Memory Test - 3 months follow-up

    Time frame: At follow-up visit 3 months after end of intervention

    Test of working memory. The higher score the better (theoretically infinite score)

  2. Minimum Data Set-Home Care- Instrumental Activities of Daily Living (MDS-HC-IADL)

    Time frame: At follow-up visit 3 months after the end of the intervention

    Questionnaire concerning activities of daily living. 0-3 points on an 8-item scale, the fewer points the better.

  3. Trail Making A

    Time frame: Directly after the intervention, eight weeks after inclusion

    Test of processing speed and visual attention. The lower score the better (theoretically infinite score)

  4. Trail Making A

    Time frame: At follow-up visit 3 months after the end of the intervention

    Test of processing speed and visual attention. The lower score the better (theoretically infinite score)

  5. Trail Making B

    Time frame: Directly after the intervention, eight weeks after inclusion

    Test of divided attention, mental flexibility. The lower score the better (theoretically infinite score)

  6. Trail Making B

    Time frame: At follow-up visit 3 months after the end of the intervention

    Test of divided attention, mental flexibility. The lower score the better (theoretically infinite score)

  7. SDMT

    Time frame: Directly after the intervention, eight weeks after inclusion

    Symbol Digit Modalities Test: Test of mental speed. The higher score the better (theoretically infinite score)

  8. SDMT

    Time frame: At follow-up visit 3 months after the end of the intervention

    Symbol Digit Modalities Test: Test of mental speed. The higher score the better (theoretically infinite score)

  9. Phonological verbal fluency test

    Time frame: Directly after the intervention, eight weeks after inclusion

    Test of verbal phonological fluency. The higher score the better (theoretically infinite score)

  10. Phonological verbal fluency test

    Time frame: At follow-up visit 3 months after the end of the intervention

    Test of verbal phonological fluency. The higher score the better (theoretically infinite score)

  11. Categorical verbal fluency test

    Time frame: Directly after the intervention, eight weeks after inclusion

    Test of verbal categorical fluency. The higher score the better (theoretically infinite score)

  12. Categorical verbal fluency test

    Time frame: At follow-up visit 3 months after the end of the intervention

    Test of verbal categorical fluency. The higher score the better (theoretically infinite score)

  13. Fear questionnaire

    Time frame: Directly after the intervention, eight weeks after inclusion

    Questionnaire with 24 items concerning fear on a scale from 0 to 8 where 8 indicates a higher degree of avoidance due to fear

  14. Fear questionnaire

    Time frame: At follow-up visit 3 months after the end of the intervention

    Questionnaire with 24 items concerning fear on a scale from 0 to 8 where 8 indicates a higher degree of avoidance due to fear

  15. mrs: Modified Rankin Scale

    Time frame: Directly after the intervention, eight weeks after inclusion

    Questionnaire concerning disability on a scale from 0 (no symptoms) to 6 (dead): Higher score indicates more severe disability.

  16. mrs: Modified Rankin Scale

    Time frame: At follow-up visit 3 months after the end of the intervention

    Questionnaire concerning disability on a scale from 0 (no symptoms) to 6 (dead). Higher score indicates more severe disability.

  17. IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly)

    Time frame: Directly after the intervention, eight weeks after inclusion

    Cognitive decline in the elderly, reported by partner. A scale of 16 items from 1 (much better) to 5 (much worse). Higher score indicates more severe disability.

  18. IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly)

    Time frame: At follow-up visit 3 months after the end of the intervention

    Cognitive decline in the elderly, reported by partner. A scale of 16 items from 1 (much better) to 5 (much worse). Higher score indicates more severe disability.

  19. EuroQol-5 domain (EQ-5D-5L)

    Time frame: Directly after the intervention, eight weeks after inclusion

    Quality of life scale with 5 domains, each rated from 1-5 indicating slight to severe disability . Higher score indicates more severe disability. Completed by patient and partner

  20. EuroQol-5 domain (EQ-5D-5L)

    Time frame: At follow-up visit 3 months after the end of the intervention

    Quality of life scale with 5 domains, each rated from 1-5 indicating slight to severe disability. Higher score indicates more severe disability. Completed by patient and partner

  21. PDQ 39 (Parkinsons Disease Questionnaire: Only in patients with Parkinson Disease)

    Time frame: Directly after the intervention, eight weeks after inclusion

    Quality of Life questionnaire in patients with Parkinson's Disease. A scale with 39 items rated from 1 (never) to 5 (all the time / Can not do at all). Higher score indicates more severe disability.

  22. PDQ 39 (Parkinsons Disease Questionnaire: Only in patients with Parkinsons Disease)

    Time frame: At follow-up visit 3 months after the end of the intervention

    Quality of Life questionnaire in patients with Parkinson's Disease. A scale with 39 items rated from 1 (never) to 5 (all the time / Can not do at all). Higher score indicates more severe disability.

  23. Compliance

    Time frame: Directly after the intervention, eight weeks after inclusion

    Monitoring of total time spent training in minutes

  24. PHQ-9 (Patient health questionnaire 9)

    Time frame: Directly after the intervention, eight weeks after inclusion

    Questionnaire about health of patient with 9 items rated on a 4 point scale from 0 (not at all) to 3 (almost every day). Higher score indicates more severe disability.

  25. PHQ-9 (Patient health questionnaire 9)

    Time frame: At follow-up visit 3 months after the end of the intervention

    Questionnaire about health of patient with 9 items rated on a 4 point scale from 0 (not at all) to 3 (almost every day). Higher score indicates more severe disability.

  26. 2) visual analogue scale (1-10)

    Time frame: Directly after the intervention, eight weeks after inclusion

    After last session: how much they liked doing the training and if they would recommend the intervention to somebody else in their situation. Higher score indicates they liked the training more.

  27. Minimum Data Set-Home Care- Instrumental Activities of Daily Living (MDS-HC-IADL)

    Time frame: Directly after the intervention, eight weeks after inclusion

    Questionnaire concerning activities of daily living. 0-3 points on an 8-item scale, the fewer points the better.

Study contacts

Contact information is provided by the study sponsor or research team.

Hanne Christensen, Professor

CONTACT

[email protected]

+45 38 63 50 70

Katrine Sværke, M.Sc. Psych.

CONTACT

[email protected]

004521251087

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • Aalborg University Hospital
  • Copenhagen Trial Unit, Center for Clinical Intervention Research
  • Göteborg University
  • Hjernesagen
  • Neurorehabilitering - Kbh, City of Copenhagen
  • Rigshospitalet, Denmark
  • University of Basel
  • University of Glasgow

Registry information

Official study title

Computer-Assisted Self-Training to Improve Executive Function Versus Unspecific Training in Patients After Stroke, Cardiac Arrest or in Parkinson's Disease: a Randomized Controlled Trial

Acronym: COMPEX

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Jan 14, 2020
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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